MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON-MR1

Model Number	1610100
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites.A detailed investigation was performed by an expert from the technical service: no further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.Patient involvement was not indicated.The root cause was not fully determined and may be connected to the component.No correction was however.Conducted as the issue did not show up during the service maintenance.There was no patient or user harm.
Event or Problem Description
Te231008 - o2-valve leak occured.Cannot reproduce error message.
Additional Manufacturer Narrative
The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites.A detailed investigation was performed by an expert from the technical service: no further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.Patient involvement was not indicated.The root cause was not fully determined and may be connected to the component.No correction was however conducted as the issue did not show up during the service maintenance.There was no patient or user harm.Hamilton medical ag complaint number: (b)(4).Follow-up 1 - corrected information: **udi related data quality updates only** field d4 was updated with full udi information as requested.
Event or Problem Description
Te231008 - o2-valve leak occured.Cannot reproduce error message.
Additional Manufacturer Narrative
The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites.A detailed investigation was performed by an expert from the technical service: no further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.Patient involvement was not indicated.The root cause was not fully determined and may be connected to the component.No correction was however conducted as the issue did not show up during the service maintenance.There was no patient or user harm.Hamilton medical ag complaint number: (b)(4).Follow-up 2 - corrected information: **udi related data quality updates only** field d4 was updated with full udi information as requested.
Event or Problem Description
Te231008 - o2-valve leak occured.Cannot reproduce error message.

• Brand Name: HAMILTON-MR1
• Common Device Name: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: andre sonnenberg ; via crusch 8; bonaduz, graubunden 7402 ; SZ 7402
• MDR Report Key: 18334911
• Report Number: 3001421318-2023-10121
• Device Sequence Number: 18246624
• Product Code: CBK
• UDI-Device Identifier: 07630002813556
• UDI-Public: (01)07630002813556(11)220301(240)1610100
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K153046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1610100
• Device Catalogue Number: 1610100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 08/09/2024; 08/09/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 08/29/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown